Parexel Blog
Parexel Blog
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Learn MoreCritical CGMP Compliance Risks Go Beyond The CEO and The Park Doctrine
If you work in the pharmaceutical industry or follow the industry news, you’ve likely heard the phrases “Park doctrine” or “responsible corporate officer (RCO) doctrine” mentioned when the...
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Learn MoreCapturing the patient voice in market access communications
Patients have unique perspectives on their conditions that, when incorporated into value communications, can provide an authenticity and salience which would otherwise be lacking. Who knows...
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Learn MorePodcast: Driving Drug Development Innovation Through Patient Centricity
This PharmaVoice podcast explores patient-centric trials as a key innovation in drug development.
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Learn MoreThe Ins and Outs of Incorporating Patient Centricity in Drug Development
This article was original published in Pharmaceutical Executive Magazine. The cost of drug R&D doubled between 2003 and 2016, according to The Innovation...
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Learn MoreNew Post-Market Surveillance Requirements (PMS) for all Medical Device Manufacturers
With a three (3) year transition period, the European Medical Device Regulation (MDR) replaces the current Medical Device Directives from May 26, 2020 on. Article 120, however, allows legal...
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Learn MoreTips from FDA – Put Design of Experiments to Use in Drug Applications
One of the benefits to having worked at FDA was the opportunity to gain exposure to how a wide variety of manufacturers perform product development and manufacturing and how they present...
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Learn MoreAddressing drug development challenges that are unique to patients with rare diseases
Zizi Imatorbhebhe, MBA MS PMP® Senior Director Integrated Solutions, and Kemi Olugemo, MD Senior Medical Director, Global Therapeutic Head CNS share their insights on tackling hurdles to...
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Learn MoreParexel & SCRS - Aligning Sites with Patient Needs to Increase Engagement
In clinical development, patient engagement is critical to success. However, when we talk about patient engagement, we can’t overlook the important role that investigative sites play in this...
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Learn MoreCriticality of Institutional Biosafety Committee for Clinical Studies of Cell and Gene Therapy Products
Conducting clinical trials for innovative gene therapy products that include viral vector-based products and gene-modified cells is not entirely straightforward. Operationally, there are...
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Learn MoreWhat you need to know about FDA’s NEW draft Drug Master Files Guidance for Industry
Drug Master Files (DMFs) may be submitted to the FDA to provide confidential and often proprietary information regarding facilities, processes, or components used in the manufacturing,...
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Learn MoreFurther Limits on The Use of Guidance for Enforcement – How Will FDA React?
On October 9, 2019, the President signed two executive orders that address how the federal government develops guidance and limits the use of guidance in civil administrative enforcement...
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Learn MoreThe Evolving Role of Medical Affairs
The role of Medical Affairs professionals is evolving at a rapid rate. In addition to providing scientific support, Medical Affairs now has much greater strategic importance by providing...
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Learn MoreDeveloping a better Global Value Dossier
The global value dossier (GVD) has become a standard tool throughout the life sciences industry for supporting product launch and local health technology assessment (HTA) submissions. There...
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Learn MoreRegulatory Update: Patient Engagement in Drug Development
This month, the FDA released a draft of its second patient-focused drug development (PFDD) guidance document, detailing best practices for understanding patient experiences and the related...
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Learn MoreCan FDA Disperse the Perfect Storm Forming Around Poor Pharmaceutical Quality?
Certain areas of the global biopharmaceutical market continue to struggle with poor product quality, which has impacted the U.S. market and its patients. This is a result of a perfect storm...
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Learn MoreWhat FDA Considers When Assessing Microorganisms in Non-Sterile Drug Products
The presence of microorganisms in sterile drug products is of paramount concern to patient safety. However, it may be less obvious why concern for the presence of microorganisms in...
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Learn MoreAdvice for Handling Potentially Mutagenic Impurities in Regulatory Submissions
The presence of various nitrosamine-related impurities in the angiotensin II receptor blocker (ARB) class of drugs and now ranitidine has been the subject of numerous pieces in the popular...
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Learn MoreAsk the Expert Blog Series: Cardiovascular Disease – Heart Failure
Lazar Mandinov, M.D., Ph.D., is a Senior Medical Director within Parexel’s Global Medical Services division. A board-certified physician, Lazar has more than 15 years of experience in...
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Learn MorePAI Objectives Remain the Same, However Important Updates are Included
Having been involved with the Concept of Operations for Integration of FDA Facility Evaluation and Inspection Program for Human Drugs while at FDA, I am encouraged to see the release of a...
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Learn MoreReimagining the Global Value Dossier (GVD)
Almost all companies with a product in development will develop a global value dossier (GVD) to support launch. Every product needs a well-defined value strategy that answers the question...
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